Saw Palmetto (Serenoa repens) is a shrubby palm that grows only in the southeastern United States, and is most prolific on pine flatwoods in peninsular Florida and southern Georgia. The saw palmetto grows a seed stalk (spadix) in late spring, which flowers and then develops a hard green fruit about the size of a small olive. The fruit ripens in the summer, turning shades of yellow, orange and black. The ripe fruit is then harvested by hand during the late summer and early fall. Typical yields in harvestable areas range from a low of 200 pounds to more than 1,000 pounds of berries per acre.
Saw palmetto berries have been ingested by Native Americans for many centuries. Early in the 20th century, naturopathic physicians in the U.S. began prescribing a tea made from saw palmetto berries as a mild diuretic and for genitourinary problems. It became a popular male tonic, but eventually the therapeutic value of the tea (a water extract) came into question and in the early 1940's it lost both its popularity and its inclusion in the National Formulary. Research in Europe in the 1960's led to the identification of the lipid portion of the berry and its medically active components, including free fatty acids and sterols, also referred to in the art as phytosterols, since they originate in plant tissue.
In recent years, saw palmetto extracts have been increasingly used by consumers to treat prostate disorders. Saw palmetto extracts may be produced by a variety of processes that remove oil from the saw palmetto berry, leaving the inert berry mass that is discarded. Most saw palmetto extracts are made using supercritical CO2 extraction. The saw palmetto berries are broken down into free fatty acids, phytosterols (plant sterols), free fatty acids and monoglycerides to form the saw palmetto extract. The United States Pharmacopeia (USP) has developed some minimum standards for saw palmetto extract as a nutraceutical supplement based on the total fatty acids, fatty acid profile, total fatty alcohols, and phytosterol levels. These standards are set forth in the U.S. Pharmacopeia Saw Palmetto Extract, USP 26-NF21, First Supplement 2003, pages 3024-25, the disclosure which is hereby incorporated by reference in its entirety.
The saw palmetto, fat soluble extract from saw palmetto berries is believed to inhibit the conversion of testosterone (DHT), which is thought to be responsible for enlarging the prostate. Also, the saw palmetto extract may inhibit the binding of DHT to receptors, thus blocking DHT's action and promoting the breakdown of that compound.
U.S. Nutraceuticals manufactures and sells saw palmetto extracts such as described in commonly assigned U.S. Pat. Nos. 6,319,524 and 6,669,968, the disclosures which are hereby incorporated by reference in their entirety. It has been determined that the free fatty acid content that is particular to saw palmetto extracts, such as the CO2 extracts, are not triacylglycerides similar to many seed oils. Instead, they are acidic free fatty acids and somewhat unusual as seed oil extracts that are usually neutral triacylglycerides. These acidic free fatty acids are not compatible with lycopene, which is often used to treat prostate deficiencies and aid in preventing prostate cancer. It is desirable to be able to present both the saw palmetto extract and the lycopene together in one oral dosage form without degrading the lycopene that would result when the lycopene is mixed with the higher acidic levels of the saw palmetto extract. Both lycopene and saw palmetto extract have been clinically evaluated and shown to be effective in maintaining prostate health. Saw palmetto extract has been shown to mitigate the symptoms of benign prostatic hyperplasia (BPH), while lycopene has been shown to be effective in possibly preventing prostate cancer.